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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD CASSETTE SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD CASSETTE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2022
Event Type  malfunction  
Manufacturer Narrative
Catalog number is unknown. Udi information is unknown. Premarket (510k) number is unknown. No lot number was provided; therefore, device history record review could not be completed. No product sample was received; therefore, visual and functional testing could not be performed. The reported issue could not be confirmed as no product sample was received for evaluation. If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
Event Description
It was reported that the disposable cassette was leaking medication from the tubing. No patient injury was reported.
 
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Brand NameCADD CASSETTE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15245588
MDR Text Key298154915
Report Number3012307300-2022-08528
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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